CSRC Annual Meeting 2015
White Oak Facility, FDA Headquarters • Silver Spring, Maryland• February, 19 2015
Meeting Agenda
8:00am-5:05pm
| Session Time | Topics & Speakers |
|---|---|
| 8:00am-8:10am | Introduction– Philip Sager, MD (Stanford University/Sager Consulting Experts) (10min) |
| 8:10am-9:55am | Plenary Session: The Landscape for Innovation in CV Safety Moderators: Mitchell Krucoff, M.D., FDA Priorities and the CSRC – Robert M. Califf, M.D. (20min) DIA Priorities and the CSRC– Barbara Lopez Kunz (20min) Panel Discussion (65min) Speakers and John Finkle, MD GSK 9:55am-10:10am-Break (15min) |
| 10:10am-11:40am | Mini- Think Tank 1: Replacing the Thorough QT Study-Is The Time Now? Moderators: Philip Sager, M.D., Borje Darpo M.D., Ph.D. CSRC/IQ- use of early human study QT date to replace the TQT Results of the prospective study and implications- Borje Darpo M.D., Ph.D. (Consultant) (15min) CIPA- replacing the TQT with non-clinical proarrhythmia testing? What is the need for a new paradigm and Current status, opportunities, and challenges- Hugo Vargas, Ph.D. (Amgen) (20min) Panel Discussion (55mins) Norman Stockbridge, M.D., Ph.D. (FDA), Christine Garnett, Pharm.D.(FDA), Corina Dota, M.D.(AstraZeneca) |
| 11:40am-12:25pm | CSRC Think Tank Updates Moderators: John Finkle, M.D. (GSK), Jerrold Levy, M.D. (Duke University) Key issues concerning the development of reversal agents for novel anticoagulants- Consensus pathway forward and how to evaluate post-marketing risk- Jeffrey Weitz, M.D. (McMaster University) (10min) Use and feedback on the CV data collection forms- Mary Beth Sabol, M.D. (GSK) (10min) Brief Panel Discussion (25min) Speakers and Jonathan Seltzer, M.D., MBA (ACI Clinical) 12:25pm-12:55pm-Working Lunch (30min) |
| 12:55pm-3:05pm | Mini-Think Tank 2: CV Outcome Studies and Scientific Advances in Registries to Evaluate CV Safety Moderators: Jeffrey Anderson, M.D. (Intermountain Heart Institute) Thresholds for requiring Randomized CV outcome studies for safety assessment Updates from the CSRC Outcome Study Thresholds Think tank and future directions- Philip Sager, M.D. (Sager Consulting Experts)(10min) FDA Viewpoint- Thresholds for requiring CV Outcome studies for safety-Norman Stockbridge, M.D., Ph.D. (FDA)(10min) How is benefit and risk appropriately balanced with respect to CV outcomes (to include a discussion of hazard ratio selections and number needed to harm boundaries)?- Sanjay Kaul, M.D., Ph.D (Cedar-Sinai Medical Center)(10min) The roles for Adjudication of CV Events in drug development- Jonathan Seltzer, M.D., MBA (ACI Clinical)(10min) Registries for CV Safety Assessment Methodological issues in safety signal detection using heterogeneous data sources and the accuracy of diagnoses - Sharon- Lise Normand, Ph.D. (Harvard University)(10min) The use and challenges of using electronic health care data for CV safety assessment David Graham, M.D., MPH(FDA) (10min) Panel Discussion (60min) 3:05pm-3:35pm-Break (30min) |
| 3:35pm-4:05pm | Abstract presentations on potential new CSRC initiatives Moderators: Catherine Ortemann-Renon, Pharm.D., Ph.D. (Sanofi) Abstract Update: Drug-Induced Cardiac Abnormalities in Premature Infants and Neonates- Luana Koplowitz, M.D., Ph.D. (Duck Flats)(8mins) Concentration-QTc analysis to obviate the need for a dedicated QTc study in cancer patients: ixazomib, an oral proteasome inhibitor, as a case study- Neeraj Gupta, Ph.D. (Takeda)(8min) Arrhythmia Normal Limits in Healthy Clinical Research Volunteers- Polina Voloshko, M.D. (Cardiocore)(8min) |
| 4:05pm-5:05pm | Areas of future direction and impact for the CSRC Moderators: Theresa Wright, M.D. (Eli Lilly), Mary Jane Geiger, M.D., Ph.D. (Regeneron) Global Regulatory and Academic Partnerships- How Can The CSRC Increase Its Impact Regulatory Japan- Kaori Shinagawa, M.D., Ph.D. (PMDA)(5min) Canada- Colette Strnadova, Ph.D. (Health Canada) (5min) CDER- Norman Stockbridge, M.D. Ph.D. (FDA)(5min) Academic Jeffrey Anderson, M.D (Intermountain Heart Institute)(5min) Sanjay Kaul, M.D., Ph.D. (Cedar-Sinai Medical Center)(5min) Panel Discussion (60min) Speakers and John Finkle, M.D. (GSK), Mitchell Krucoff, M.D. (Duke University), Philip Sager, M.D.,(Sager Consulting Experts) |